2022 Rome Action Plan on Paediatric HIV & TB
Johnson & Johnson
Johnson & Johnson, for the long-acting formulation CAB LA + RPV LA, commits to:
39. Support investigators to permit women who become pregnant during a study to continue taking CAB LA + RPV LA during their pregnancy, if they wish to, following a risk benefit discussion with their provider, and according to local regulatory approval and label.
40. Support and facilitate data collection of pregnancy, birth, lactation, and infant safety outcomes for CAB LA + RPV LA via ongoing research (clinical trials and implementation research), and if needed, with rapid initiation of additional dedicated studies.
41. Collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) from post-marketing surveillance in women who receive CAB LA + RPV LA treatment during pregnancy
All partners commit to:
163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment.
164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care.
165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.
166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.
Johnson & Johnson commits to:
378. Ensuring ongoing access to the 20mg bedaquiline tablet, which Johnson & Johnson, in partnership with Stop TB Partnership's GDF Paediatric DR-TB Initiative, has already made available for over 130 countries, following US FDA approval in May 2020.
379. Continue efforts in exploring additional clinical trial sites to ensure timely completion of study investigating the use of bedaquiline in children below 5 years of age.
380. Engage early and regularly with GAP-f and other WHO-convened expert groups on paediatric drug and regimen development, including target regimen profile consultations for paediatric DR-TB regimens.
381. Make paediatric formulations and data available to research networks advancing paediatric PK and safety studies where appropriate under collaborative agreements. Rapidly submit paediatric data to regulatory authorities and the WHO to facilitate updating of labelling and treatment guidelines.
382. Use the following best practices for the design and implementation of research studies in paediatric populations:
i. Engage with regulators to explore options for paediatric studies as soon as a given drug shows promising efficacy and safety in Phase IIa adult studies.
ii. Consider including adolescents when conducting initial adult efficacy trials or conduct parallel trials with the goal of providing information to support licensing for adolescents at or near the same time as adults, when appropriate from a scientific and ethical perspective and allowed by regulations.
iii. In the design of paediatric PK and safety studies, when appropriate from a scientific and ethical perspective and allowed by regulations, consider studying weight-based dosing and enrolling all children above 4 weeks of age concurrently (i.e., no age de-escalation)
iv. Assess acceptability and palatability of paediatric formulations, including for use in low-resource settings, at the earliest appropriate stage of the formulation’s development.
383. Consider the use of reliance regulatory procedures, including the WHO collaborative Registration Procedure (CRP), for national registration of paediatric TB products.
384. Ensure all drug registration dossiers for paediatrics (including an age-appropriate formulation), meet requirements at the time of filing and that responses to specific queries are complete and provided in a timely manner.
385. Consider providing multilingual paediatric patient information leaflets to facilitate appropriate use by healthcare workers and caregivers.
386. Consider prioritizing registration submission of new TB paediatric products in high burden countries where import waivers cannot be granted.
387. Assuming there are no contraindications to use in pregnancy from pre-clinical studies, Johnson & Johnson supports inclusion of women who become pregnant in clinical trials by allowing them to remain on study drug with consent.